On May 11, 2005, Cephalon, Inc. issued a press release announcing a halt to its Phase 2/3 clinical trial for CEP-1347 (1), an experimental drug hoped to be a unique neuroprotective agent that might slow or even reverse the progression of Parkinson’s disease. The decision was based on an interim review by an independent data monitoring committee that concluded “final data would not likely provide evidence of significant effect, though … specific findings [were] not yet …revealed to Cephalon. There were no safety concerns.” (2)
Data from a two year period was analyzed for 200 out of the total 800 human volunteers. The clinical trial was conducted by the Parkinson Study Group. Outcome measures were the time to initiation of dopaminergic therapy, and an evaluation of disease progression through SPECT imaging.
None of the 800+ trial participants, their doctors, or the study centers received notification from Cephalon or its European partner Lundbeck before the trial’s abrupt halt was announced on Internet news sites, and spread via e-mails and phone calls among participants and to study centers. Critical questions remained unanswered, such as should participants:
continue to take the trial medication ?
titrate their dosages down gradually or stop cold turkey?
keep scheduled appointments for tests, scans or physicals?
Participants also wanted to know whether they had received the study treatment or a placebo, especially since the use of CEP-1347 is suspected to increase the risk of developing cancer, especially skin cancers.
Some participants had been promised copies of their medical records, such as their brain scans, when the trial ended. They received conflicting responses about being able to access these.
It took another four days for participants to be contacted and receive information from their trial centers. This delay in notifying the study centers, doctors and trial participants of the halt, aggravated a disappointing and difficult situation. As one trial participant wondered, “Why did Cephalon not first contact the people involved in the study with an explanation and instructions before making a public announcement? To leave everyone – the study centers and the participants - in limbo is callous, unprofessional, and potentially dangerous to our health.” (3)
Situations like this prompted the Parkinson Pipeline Project to recently draft a Bill of Rights for Parkinson’s Research Participants (http://www.pdpipeline.org/rights.htm). It addresses the need for sponsors to have a protocol in place in the event of a trial halt, and to involve all stakeholders -- patients, caregivers and members of the research team -- in the decision making process. The document also acknowledges patients’ rights to receive medical information in a timely manner, including the results and interpretations of their own tests and measurements taken during the course of the trial.
1. “Cephalon and H. Lundbeck Announce Discontinuation of CEP-1347 Clinical Trial in Parkinson's Disease" Retrieved online 5/11/05 through PR Newswire. http://www.prnewswire.com [2/11 item is no longer available online]
2. Lorenzo, Aaron. “Cephalon's Parkinson's Study Stopped; No Benefit Showed.” May 13, 2005. Retrieved online through BioWorld www.BioWorld.com
3. Burns, Jean. “Op/Ed on Cephalon Trial Halt.” Grass Roots Connection web site. Retrieved online May 22, 2005. http://www.grassrootsconnection.com/OpEds.htm [no longer online]